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NCT Number: NCT07116369

Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.

This study aims to evaluate whether integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score can improve the early prediction of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. SBP is a common and potentially life-threatening complication of cirrhosis. Identifying at-risk patients early using simple, routine laboratory parameters could enhance risk stratification, guide monitoring strategies, and reduce associated morbidity and mortality.

Participants will be Adult patients (≥18 years) with liver cirrhosis and ascites undergoing diagnostic paracentesis at Sohag University Hospital.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is a prospective observational study designed to enhance the prediction of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis and ascites by integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score. SBP remains a serious and potentially fatal complication in cirrhotic patients, with delayed diagnosis contributing to poor outcomes. The ALBI score, which reflects liver function objectively, along with hyponatremia and thrombocytopenia-common in cirrhosis-may provide a simple, low-cost method for early identification of patients at high risk for SBP.

The study will be conducted over 6 months at the Internal Medicine and Hepatology Units, Sohag University Hospital. All eligible adult patients (≥18 years) with liver cirrhosis and ascites who undergo diagnostic paracentesis will be screened for inclusion.

Inclusion criteria

include cirrhotic patients with ascites undergoing diagnostic paracentesis.

Exclusion criteria

include secondary peritonitis, advanced hepatocellular carcinoma, obstructive jaundice, recent antibiotic use (<7 days), end-stage renal disease requiring dialysis, current use of immunosuppressive therapy, and incomplete data.

Each participant will undergo clinical evaluation and laboratory testing, including serum albumin, bilirubin (for ALBI calculation), sodium, and platelet count. Ascitic fluid analysis will be performed to diagnose SBP based on PMN count ≥250 cells/mm³.

The study will assess whether a combined score (ALBI-Na-Platelet) can improve prediction accuracy. Statistical analysis will involve logistic regression and ROC curve analysis to evaluate the predictive power of the combined parameters.

All participants will provide written informed consent. The study is approved by the Medical Ethics Committee of Sohag University, Faculty of Medicine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis.

Exclusion criteria

  • obstructive jaundice
  • Recent antibiotic use < 7 days
  • Secondary pertonitis (bowel perforation)
  • Advanced Hepatocelluar carcinoma
  • End-stage renal disease requiring dialysis
  • Use of immunosuppressive therapy
  • Incomplete laboratory or clinical data.

Treatment and study plan

Primary outcomes

  1. Occurrence of SBP, ALBI score, s.sodium, platelet count

    Time frame: Within 1 week

    Outcome of SBP in cirrhotic patients by measurement of ALBI score, platelet count and s.sodium

Study contacts

Contact information is provided by the study sponsor or research team.

Shimaa H Mahmoud, MBBS

CONTACT

[email protected]

+201120237891

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Enhancing Prediction of Spontaneous Bacterial Peritonitis in Liver Cirrhosis by Integrating Serum Sodium and Platelet Count With the Albumin-Bilirubin Score .

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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